0.

8% RESOLVE Panel C

Reagent Red Blood Cells

0.8 % RESOLVE® Panel C System
0.8% RESOLVE® Panel C Untreated
0.8% RESOLVE® Panel C Ficin
Treated
INSTRUCTIONS FOR USE
6902319

Rx ONLY

Intended Use
For in vitro diagnostic use
For the identification of unexpected blood group antibodies in the ID-Micro Typing System™ Gel Test methods.

Summary and Explanation of the Test

Unexpected antibodies detected in serum or plasma must be identified to determine clinical significance. Antibody
identification is accomplished by testing the serum or plasma against a panel of reagent red cells bearing different antigens.
The presence or absence of red cell agglutination or hemolysis is determined and compared with the antigen profile of the
reagent cells. With samples that contain multiple antibody specificities or exhibit weak reactivity, it may be necessary to use
additional test methods to identify the antibody specificity(ies). The use of enzyme-treated reagent red cells is one of the
primary means by which antibody differentiation and recognition can be accomplished.
Proteolytic enzymes modify red cell antigens in ways that enhance the reactivity of some antigen/antibody reactions and
destroy or alter others. The reactions of Rh, Lewis, Kidd and P system blood group antibodies are usually enhanced along
with most cold agglutinins. Enzyme treatment destroys or alters antigens in the MNS and Duffy systems as well as Xga, Pr,
Cha, Rga and JMH, thus reducing or eliminating the reactivity of the corresponding antibody. Some antibodies may become
hemolytic in the presence of enzyme-treated reagent cells and fresh serum.
0.8% RESOLVE Panel C System consists of untreated and ficin-treated panels of reagent red cells from 11 group O
individual donors and an ANTIGRAM® Antigen Profile for use in antibody identification studies. Testing with ORTHO 0.8%
RESOLVE Panel C Ficin Treated may be performed concurrently or subsequent to testing with 0.8% RESOLVE Panel C
Untreated. Serologic studies with ficin-treated reagent red cells should be considered adjunct tests and not be used as the
sole means of antibody identification.

Principles of the Procedure

Using the conditions under which the antibody was originally detected, the serum/plasma is combined with a sample of
each panel member. Agglutination and/or hemolysis indicates the presence of an antibody or antibodies directed against an
antigen present on the corresponding reagent red cell. Antibody identification is facilitated by recording the results of testing
and grading the strength of reactivity.

Reagents
0.8% RESOLVE Panel C Untreated is a series of human red blood cells in 0.8% suspensions from 11 group O individuals.
0.8% RESOLVE Panel C Ficin Treated consists of the same corresponding red blood cells that have been treated with the
proteolytic enzyme ficin prior to suspension. The accompanying ANTIGRAM Antigen Profile lists the blood group factors
determined to be present on (+) and absent from (0) each red blood cell.
The cells are suspended in a low ionic strength diluent, to which a purine and nucleoside have been added to maintain
reactivity and/or retard hemolysis during the dating period. Trimethoprim (32 μg/mL) and sulfamethoxazole (160 μg/mL)
have been added to retard bacterial contamination.
Use 0.8% RESOLVE Panel C Untreated and 0.8% RESOLVE Panel C Ficin Treated directly from the vials. As with all
reagent red blood cells, the reactivity of the cells may decrease during the dating period. The rate at which antigen
reactivity (e.g., agglutinability) is lost is partially dependent upon individual donor characteristics that are neither controlled
nor predicted by the manufacturer.
Do not use if marked hemolysis, discoloration or evidence of contamination is observed.
No U.S. Standard of Potency.
• Do not freeze.

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Specimen Collection, Preparation and Storage

• Do not use beyond expiration date.

• The expiration date of each lot is no longer than 77 days from the date of collection of red blood cells from any donor in
the lot.
• Studies demonstrate consistent performance of this product from the time the vial is opened until the specified expiration
date.
• Store at 2–8 °C.

Caution: All blood products should be treated as potentially infectious. Source material from
which this product was derived was found negative when tested in accordance with
current FDA required tests. No known test methods can offer assurance that
products derived from human blood will not transmit infectious agents.

Specimen Collection, Preparation and Storage

• Either serum or plasma may be used.
• Specimen collection should be accomplished by accepted medical procedures.
• No special preparation of the patient is required prior to specimen collection.
• Bacterial contamination may interfere with the results and interpretation of the test.
• Specimen storage should be within applicable regulating agencies’ requirements.
• If specimens are stored before testing, they should be stored at 2–8 °C.

Procedure
This product is to be used directly from the vial without further modification. The contents of each vial should be
resuspended by gently mixing.

ID-Micro Typing System

The use of ID-Micro Typing System Anti-IgG Gel Card is recommended for use with Untreated RESOLVE Panel C cells.
The use of ID-Micro Typing System Buffered Gel Card is recommended for use with Ficin Treated RESOLVE Panel C cells.
Refer to the appropriate ID-Micro Typing System Instructions for Use for test method instructions. For supplemental reagent
red cells or autologous red cells that require modification to a 0.8% concentration prior to testing, refer to the appropriate
ID-Micro Typing System Instructions for Use for test method instructions.

Materials Provided
0.8% RESOLVE® Panel C Untreated
0.8% RESOLVE® Panel C Ficin Treated

Materials Required but Not Provided

Please refer to the ID-Micro Typing System Instructions for Use for additional materials required for use.
• ORTHO® Workstation
• ORTHO Optix™ Reader
• ORTHO VISION® Analyzer
• ORTHO VISION® Max Analyzer

Results
Interpretation
1. Hemolysis or agglutination is a positive test result and reflects the presence of an antibody-antigen reaction.
2. No hemolysis or agglutination is a negative test result and indicates the absence of an antibody-antigen reaction.
3. Identification of the antibody present in the serum/plasma may be made by matching the reactions obtained with the
ANTIGRAM Antigen Profile furnished with the reagent. If the antibody specificity is not evident, testing with additional
cells may be required.
4. Reactions obtained with 0.8% Resolve Panel C Ficin Treated are likely to be different than the reactivity obtained with
the untreated panel as reactivity with certain antibodies will be enhanced while others are diminished or eliminated.
Interpretation must be made considering the various effects of enzymes in antigen/antibody reaction.
The following specificities are examples of antibodies whose reactivity may be enhanced when testing is performed with
‒
ficin-treated red cells: Anti-D, -C, -E, -c, -e, -f, -Jka, -Jkb, -Leb, -P1, -I, -IH, -Vel, -PP1Pk and -P.

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Control of Error

The following specificities are examples of antibodies whose reactivity may be eliminated or reduced when testing is
‒
performed with ficin-treated red cells: Anti-Fya, -Fyb, -M, -N, -S, -s, -Xga, -Pr, -Cha, -Rga and JMH.

Stability of Final Reaction Mixture

All results should be read and recorded upon test completion.

Control of Error
For quality assurance, 0.8% RESOLVE Panel C Untreated and 0.8% RESOLVE Panel C Ficin Treated should be tested
periodically with weak antibodies.

Limitations of the Procedure

1. Antibodies specific for low-incidence antigens not present on the test cells will not be detected.
2. Contaminated blood specimens or test materials may interfere with the test results. Do not use if discoloration of test
column is observed.
3. Improper technique may invalidate the results obtained with these reagents.
4. False-positive test results may occur if antibodies to components of the 0.8% Red Cell Diluent are present in the sample
tested.
5. If multiple antibodies are present in the sample, testing with additional cells may be required for identification.
6. These cells are contained in a low ionic strength diluent. The addition of other potentiators to the cards is not
recommended and may affect the test results.
7. Warm or cold autoagglutinins may be enhanced in tests performed with ficin-treated red cells.
8. Excess ficin or overtreatment of cells may cause nonspecific agglutination.
9. Ficin-treated cells are more prone to lysis than untreated cells when tested against hemolytic antibodies such as anti-
Lea, anti-Leb, anti-Jka, anti-Vel and anti-PP1Pk.
10. Complement-dependent antibodies may not be detected if a plasma specimen is used.
11. A positive reactive autocontrol, using either ficin-treated or untreated cells, indicates a serological abnormality that must
be resolved before test results can be interpreted.
12. For antibody detection and identification, different serological methods are optimal for different antibodies. No single
antibody screening or identification method optimally detects all antibodies. In some low ionic strength test systems,
certain Anti-E and Anti-K antibodies have been reported to be nonreactive.

Specific Performance Characteristics

When properly stored and used for the identification of unexpected blood group antibodies, these reagent red blood cells
will aid in the identification of antibodies directed against the antigens present on them within the limitations of the
respective test system used. The complete antigen profile will vary with each individual lot of reagent red cells. The
presence or absence of each antigen listed on the accompanying ANTIGRAM Antigen Profile has been demonstrated by
testing with at least two sources of antiserum unless rarity of the antiserum precludes it. Each of these tests have been
conducted and interpreted independently. Each cell sample is shown to have a negative direct antiglobulin test, indicating
that no human IgG or human complement components are detectable on the reagent cell surface.
Technical questions concerning the reagent should be directed to Ortho Care™ Technical Solutions Center at
1-800-421-3311.

Note: For further information about the performance data using ORTHO VISION®
Analyzer, ORTHO VISION® Max Analyzer, and ORTHO Optix™ Reader, please
refer to the Instruction for Use of the related ID-Micro Typing System (ID-MTS™
Gel Card IFU).

*ID-Micro Typing System is a trademark of Micro Typing Systems, Inc.

References
1. Löw B, Messeter L. Antiglobulin test in low-ionic strength salt solution for rapid antibody screening and cross-matching.
Vox Sang 1974;26:53-61.
2. Beattie KM. Control of the antigen-antibody ratio in antibody detection/compatibility tests. Transfusion
1980;20:277-284.
3. Allan JC, Bruce M, Mitchell R. The preservation of red cell antigens at low ionic strength. Transfusion 1990;30:423-426.
4. Technical manual. 14th ed. Bethesda, MD: American Association of Blood Banks, 2002.
5. Ellisor SS. Action and application of enzymes in immunohematology. In: Seminar on antigen-antibody reactions
revisited. Washington, DC: American Association of Blood Banks, 1982:133-174.
6. Issitt PD, Anstee DJ. Applied blood group serology. 4th ed. Durham, NC: Montgomery Scientific Publications, 1998.

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Glossary of Symbols

7. Reid ME, Lomas-Francis C. Blood group antigen facts book. San Diego, CA: Academic Press, 1997.
8. Yaskanin DD, Jakway JL, Ciavarella DJ. Red blood cell diluent composition is important for detection of some anti-E.
Immunohematology 2000;16:142-146.
9. Merry AH, Thomson EE, Lagar J, et al. Quantitation of antibody binding to erythrocytes in LISS. Vox Sang
1984;47:125-132.
10. Issitt PD. From kill to overkill: 100 years of (perhaps too much) progress. Immunohematology 2000;16:18-25.

Glossary of Symbols

Revision History
Date of Revision Version Description of Technical Changes*
2021-02-23 e631202534 • Materials Required but Not Provided:
– Added ORTHO® Workstation
– Added ORTHO Optix™ Reader
– Added ORTHO VISION® Analyzer
– Added ORTHO VISION® Max Analyzer
• Specific Performance Characteristics:
– Added note for ORTHO VISION® Analyzer, ORTHO VISION® Max
Analyzer, and ORTHO Optix™ Reader performance characteristics.
• New format; technically equivalent to e631202533
* The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

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Ortho-Clinical Diagnostics, Inc.

1001 US Highway 202
Raritan, NJ 08869 USA

US LICENSE 1236 © Ortho Clinical Diagnostics, 2002–2021

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